Clinical Trial Results:
Effects of vitamin D supplementation during a non-surgical treatment of generalized chronic periodontitis: a randomized double-blinded placebo-controlled clinical trial
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Summary
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EudraCT number |
2016-005062-61 |
Trial protocol |
BE |
Global end of trial date |
28 Aug 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Feb 2021
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First version publication date |
17 Feb 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Protocol01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03162406 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Cliniques universitaires Saint-Luc
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Sponsor organisation address |
Avenue Hippocrate, 10, Brussels, Belgium, 1200
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Public contact |
Ecole de Médecine Dentaire , Cliniques universitaires Saint-Luc, 32 27645702, jerome.lasserre@uclouvain.be
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Scientific contact |
Pr. Selena Toma, EMDS - Parodontologie, 32 27645714, selena.toma@uclouvain.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Aug 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Aug 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Aug 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The study wanted to test the hypothesis that vitamin D supplementation administered as an adjuvant to initial periodontal treatment and continued for 6 months in patients with generalized chronic periodontitis (GChP) and low serum vitamin D concentrations, may lead to superior clinical results compared with the initial treatment alone. The primary objective of this study was to determine the effect of vitamin D on probing pocket depth (PPD). The secondary objective was to validate the applied VD dosage regimen.
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Protection of trial subjects |
The study was conducted in accordance with the guidelines of Good Clinical Practice and the revised Declaration of Helsinki for clinical studies
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Background therapy |
Periodontitis is a chronic inflammatory disease characterized by immunoinflammatory infiltrate in the deep compartments of the periodontium, leading to destruction of the tooth-supporting tissues, tooth mobility and eventually tooth loss. In a recent systematic review on vitamin D levels and PD, Pinto et al. reported a significant association between low 25(OH)D levels and periodontal parameters in 65% of the cross-sectional studies analyzed. Still, among the observational longitudinal studies included, the authors found no proof that the PD progression could be attributed to lower serum 25(OH)D. Similar results were reported in another systematic review on vitamin D and PD. In both reviews, however, the authors could not identify the interventional studies where only vitamin D supplementation was used as adjuvant in the treatment of PD. Therefore, there was a biologic rationale to investigate the anti-inflammatory effects of vitamin D supplementation during the treatment of periodontitis. | ||
Evidence for comparator |
Vitamin D has been proposed to have anti-inflammatory properties that could be potentially appealing in the management of PD. The inflammation, when it is fine-tuned, is one of the principal defense mechanisms of the body. There is a controversy regarding the relationship between vitamin D and inflammation. If inflammatory conditions decrease 25(OH)D concentrations, and the body utilizes vitamin D to help heal and modulate inflammation, thus, obtaining higher vitamin D serum concentrations might be of benefit in treating these disorders. However, this hypothesis is not supported by some authors. In addition, analysis of cross-sectional data of the third National Health and Nutrition Examination Survey (NHANES III) found that the serum vitamin D levels were significantly and inversely associated with bleeding on gingival probing in all age groups, and Dietrich et al. reported a possible association between low serum vitamin D levels and PD. | ||
Actual start date of recruitment |
03 Apr 2017
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
6 Months | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 27
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Worldwide total number of subjects |
27
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EEA total number of subjects |
27
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
27
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
30 years + older Caucasians (European + North African) in good general health and diagnosed with GChP based on the American Academy of Periodontology classification.They had to present a min 15 teeth (excluding 3d molars and teeth with advanced decay indicated for extraction).Serum 25(OH) vit D3 concentration for inclusion was set at <30 ng/mL | |||||||||
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Pre-assignment
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Screening details |
- | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
27 | |||||||||
Intermediate milestone: Number of subjects |
Enrollment: 27
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Intermediate milestone: Number of subjects |
Allocation: 27
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Intermediate milestone: Number of subjects |
Follow-up: 27
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Intermediate milestone: Number of subjects |
Analysis: 27
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Number of subjects completed |
27 | |||||||||
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Period 1
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Period 1 title |
Full Study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
The principal examiner (M.P.) as well as the participants were blind to the respective treatment arms until the end of the study. Allocation concealment was warranted by the use of identical vitamin D/placebo ampoules produced by the company LABORATOIRES SMB S.A., Brussels, Belgium for the needs of the present study. After randomization, the two groups were followed in exactly the same way
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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VITAMIN D | |||||||||
Arm description |
25000 IU VITAMIN D WEEKLY per 6 months | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
25000 IU VITAMIN D
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Investigational medicinal product code |
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Other name |
VITAMIN D, D-CURE
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Oral use
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Dosage and administration details |
25000 IU OF VITAMIN D PER WEEK FOR 6 MONTHS
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Arm title
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PLACEBO | |||||||||
Arm description |
Ampoules produced by the company LABORATOIRES SMB S.A., Brussels, Belgium | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Ampoules produced by the company LABORATOIRES SMB S.A., Brussels, Belgium
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Oral use
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Dosage and administration details |
1 AMPOULE OF PLACEBO PER WEEK FOR 6 MONTHS
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Baseline characteristics reporting groups
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Reporting group title |
VITAMIN D
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Reporting group description |
25000 IU VITAMIN D WEEKLY per 6 months | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
PLACEBO
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Reporting group description |
Ampoules produced by the company LABORATOIRES SMB S.A., Brussels, Belgium | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
VITAMIN D
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Reporting group description |
25000 IU VITAMIN D WEEKLY per 6 months | ||
Reporting group title |
PLACEBO
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Reporting group description |
Ampoules produced by the company LABORATOIRES SMB S.A., Brussels, Belgium | ||
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End point title |
Effect of vitamin D on non-surgical periodontal treatment [1] | ||||||||||||||||||
End point description |
The primary objective of this study was to determine the effect of vitamin D on probing pocket depth (PPD). The secondary objective was to validate the applied VD dosage regimen
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End point type |
Primary
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End point timeframe |
The effect of vitamin d was evaluated at baseline - 3 months and 6 months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The sample size was calculated by taking the PPD as the main measure with standard deviation of 0.5 mm to detect a difference of 1 mm. It took 7 subjects per group to have a power of 0.90 and 6 per group for a power of 0.80 (alpha = 0.05). To compensate for a possible dropout, an additional 20% of subjects were deemed necessary. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Effect of vitamin D supplementation on FMPS and FMBS | ||||||||||||||||||||||||
End point description |
The secondary objectives of this study are to determine the effect of vitamin D supplementation on FMPS and FMBS
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End point type |
Secondary
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End point timeframe |
The effect of vitamin D was evaluated at baseline - 3 months and 6 months
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
April 2017-September 2018
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Assessment type |
Systematic | |||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
Test group
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Reporting group description |
vitamin D supplementation | |||||||||||||||
Reporting group title |
Control group
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Reporting group description |
placebo | |||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Zero non-serious adverse events |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
